FDA UPDATES – October 2023

Published by Daniel at October 20, 2023

1. Caretaker Medical's Vital Stream has been cleared by the FDA 2. The FDA has granted clearance to an at-home test for measuring kidney function

Caretaker Medical's Vital Stream has been cleared by the FDA

This non-invasive monitoring technology has been developed to address the challenges associated with patient mobility and to eliminate the need for patients to be tethered to bedside equipment while still providing high-acuity and ICU-level hemodynamic monitoring. The technology has recently been granted clearance for four additional continuous hemodynamic parameters: cardiac output, heart rate variability, left ventricular ejection time, and stroke volume.

PDA utilizes a Finger Sensor to continuously measure blood pressure and hemodynamics, eliminating “blind spots” between manual spot-checks. This enables uninterrupted monitoring in both inpatient and outpatient settings.

Continuous monitoring with VitalStream has several advantages. It helps clinicians identify patient deterioration early on, leading to earlier intervention and optimized treatment. Additionally, it allows for the prevention of adverse outcomes resulting from hypotension or hypoperfusion. This technology is also expected to reduce risk and cost, increase patient mobility, and provide clinicians and patients with comfortable, continuous, high-acuity monitoring. VitalStream provides its readings via remote streaming to the company’s mobile app or secure cloud portal. It is integrated into other monitoring systems and EMRs with their FDA-cleared software interface SDKs. This device is currently available in the USA through the company and its distribution partners. Caretaker Medical plans to make VitalStream available in Europe and Asia later this year.

The FDA has granted clearance to an at-home test for measuring kidney function

Since the outbreak of COVID-19, home test kits have become a valuable resource that allows many individuals to avoid the risk of visiting a laboratory. One such example is the Minuteful Kidney test, developed by Healthy.io, which has received FDA approval. This at-home kidney test is designed to aid in the early detection of kidney disease and uses a smartphone and an AI-powered app. The test is based on a standard albumin-to-creatinine ratio (ACR) test, which is typically one of the first indicators of kidney injury and can assist in identifying chronic kidney disease in its early stages. The process for using the Minuteful Kidney testing kit is simple and straightforward. Firstly, the patient receives the kit in the mail. Secondly, the patient accesses the Minuteful Kidney app on their Apple or Android device to receive instructions on collecting the urine sample, using the dipstick, and placing the sample strip on a color board. Lastly, the patient takes a picture of the strip using their phone.

This app utilizes artificial intelligence technology to analyze a patient’s sample and provide immediate results. It evaluates the albumin levels in the patient and delivers the results to both the patient and their healthcare provider. This test, which can be conducted through a smartphone, enables patients to evaluate their kidney function from remote locations without needing laboratory facilities. The test is easy to use, and patients are more likely to conduct it at their homes, which can help with early diagnosis and reduce the likelihood of undergoing dialysis. This can save the healthcare system millions of hours of dialysis per year.